BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE MODEL FP7

    MDR report key: 14961204 · Received July 8, 2022

    Report

    Report Number
    1000125279-2022-00012
    Event Type
    Injury
    Date Received
    July 8, 2022
    Manufacturer
    NEW WORLD MEDICAL, INC
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE OBSERVED, PRODUCT WAS MANUFACTURED, TESTED AND RELEASED PER VALIDATED PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. UNIT HAS NOT BEEN RETURNED FOR EVALUATION. AN ADDENDUM WILL BE FILED WITH UPDATED INFORMATION IF THE UNIT IS RETURNED TO NWM FOR EVALUATION.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED, "IMPLANTED BUT IOP CONTROL DIDNT WORK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2862494 AHMED GLAUCOMA VALVE MODEL FP7 GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC FP7 M1321 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention